Krystal Biotech Reports Second Quarter 2020 Financial Results and Provides Update on Operational Progress
Initiated the pivotal GEM-3 clinical study evaluating B-VEC in DEB patients
Today announced enrollment of 1st patient in Phase 2 clinical study evaluating KB105 in ARCI patients
On track to initiate Phase 1 trial of KB301 for an aesthetic indication in 2H 2020
Strong balance sheet with
“The future of Krystal shines brighter than ever. We enter the second half of the year with a Phase 3 trial in DEB, a Phase 2 trial in ARCI and expect to initiate a Phase 1 trial in aesthetic skin conditions in the near term, leading to multiple data readouts in the next 6 to 12 months,” said
Program Highlights & Upcoming Events
Beremagene Geperpavec (B-VEC) for DEB
July 2020, Krystal announced the initiation of the pivotal GEM-3 study. The trial is a randomized, double-blind, intra-patient, placebo controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for patients suffering from both recessive and dominant dystrophic forms of Epidermolysis Bullosa. Details of the pivotal study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604.
- Top line data and Biologics License Application (BLA) filing are anticipated in 2021. Data from this trial will also form the basis of an Marketing Authorisation Application (MAA) filing in the EU which is anticipated to occur shortly after the BLA filing.
May 2020, at the Society for Investigative Dermatology(SID) annual meeting, Dr. Peter Marinkovich, M.D. (associate professor of dermatology and director of the Blistering Disease Clinicat Stanford University) presented an overview of data from the GEM-1 and GEM-2 studies.
KB105 for ARCI-Icthyosis
- Today Krystal announced the enrollment and dosing of the first patient in the Phase 2 clinical study of KB105 in patients with TGM1 deficient autosomal recessive congenital ichthyosis (ARCI). Treatment of a larger area is being evaluated. Details of the Phase 2 study can be found at www.clinicaltrials.gov under NCT identifier NCT04047732.
- Positive safety and efficacy data from the first 3 adult patients enrolled in the study were reported in
May 2020and were presented at the SID meeting by Dr. Amy S. Paller, M.D. (chair, Department of Dermatology, Northwestern University).
KB407 for Cystic Fibrosis
May 2020, at the American Society of Gene & Cell Therapy(ASGCT) meeting, Krystal presented initial in vitro pharmacology data for KB407. The data showed that our vector was able to efficiently infect Small Airway Epithelial Cells (SAEC) derived from CF patients and generate full-length, properly localized, and functional CFTR protein.
- Pre-clinical validation work is ongoing, and an IND filing is anticipated in 2021.
KB301 for Aesthetic Indications
- The Company is on track to initiate a Phase 1 clinical safety and efficacy study of KB301 for the treatment of wrinkles and acne scars in 2H 2020.
KB104 for Netherton Syndrome
- The Company continues to work towards an IND filing.
Financial results for the quarter ended
- Cash, cash equivalents and short-term investments totaled
$297.2 millionon June 30, 2020. The cash balance as of June 30, 2020reflects the receipt of net proceeds of $117.2 millionfrom the Company’s May 2020follow-on stock offering.
- Research and development expenses for the second quarter ended
June 30, 2020were $3.6 million, compared to $4.2 millionfor second quarter 2019.
- General and administrative expenses for the second quarter ended
June 30, 2020were $3.3 million, compared to $1.7 millionfor second quarter 2019.
- Net losses for the quarters ended
June 30, 2020and 2019 were $6.8 millionand $5.3 millionor ( $0.37) and ( $0.37) per common share (basic and diluted), respectively.
- For additional information on the Company’s financial results for the second quarter ended
June 30, 2020, refer to form 10-Q filed with the SEC.
About Krystal Biotech
Any statements in this press release about future expectations, plans and prospects for
Ashley R. Robinson
Source: Krystal Biotech, Inc.